MAUDE Adverse Event Report: HOLOGIC, INC THINPREP 5000 PROCESSOR

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Manufacturer Narrative

Investigation performed.The instrument finished 14 samples run without error when arrived.Performed inspection per technical documentation + global cleaning.Found rusted compressor + trace of leak below.Replaced the following parts as precautionary measure: compressor.Ran go no-go test to verify instrument operation.Processed samples to confirm operation.Instrument operational.(b)(4).

Event Description

A customer in (b)(6) reported error 6225fr016 and 6801ft026 on their thinprep 5000 processor.Customer did it and reported that slide was not done and was emptied.No sample and patient need to be recalled.While rebooting tech support (ts) heard a strong noise and suspected that's the compressor not working properly.Ts asked customer to try to run a test sample but user interface came frozen.Machine not operational.Hologic field service engineer (fse) need to be dispatched.Although the instrument produced an error code during this incident, this is a reportable event since the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.

• Brand Name: THINPREP 5000 PROCESSOR
• Type of Device: THINPREP 5000 PROCESSOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 5872688
• MDR Text Key: 52854439
• Report Number: 1222780-2016-00205
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other